IM: Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

• Sponsor: Konyang University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01499576
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 25.2

Study Details

Study Description

Brief Summary

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms; Metaplasia	Procedure: Acetic acid chromoendoscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetic acid spraying	Procedure: Acetic acid chromoendoscopy; Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Outcome Measures

Primary Outcome Measures

1. Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy [3 months after the completion of the study (a pathologist reviewed all the biopsy slide)]

   Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.

Secondary Outcome Measures

1. Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists [One month after the completion of the study]

   The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently. We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.

2. Number of Participants With Adverse Events [up to 1week after the acetic acid chromoendoscopy]

   Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Person who undergo gastroduodenoscopy

• Person who visit Konyang University Hospital

Exclusion Criteria:

• Bleeding diathesis

• History of stomach neoplasms

• History of upper gastrointestinal surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology and Hepatology; Konyang University Hospital	Daejeon		Korea, Republic of	302-718

Sponsors and Collaborators

• Konyang University Hospital

Investigators

• Principal Investigator: Kyung Ho Song, M.D., Master, Konyang University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cassaro M, Rugge M, Gutierrez O, Leandro G, Graham DY, Genta RM. Topographic patterns of intestinal metaplasia and gastric cancer. Am J Gastroenterol. 2000 Jun;95(6):1431-8.
• Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. Review.
• Lee BE, Kim GH, Park DY, Kim DH, Jeon TY, Park SB, You HS, Ryu DY, Kim DU, Song GA. Acetic acid-indigo carmine chromoendoscopy for delineating early gastric cancers: its usefulness according to histological type. BMC Gastroenterol. 2010 Aug 23;10:97. doi: 10.1186/1471-230X-10-97.

• Responsible Party: Kyung Ho Song, MD, Assistant Professor, Konyang University Hospital
• ClinicalTrials.gov Identifier: NCT01499576
• Other Study ID Numbers: 11-62
• First Posted: Dec 26, 2011
• Last Update Posted: Sep 26, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Kyung Ho Song, MD, Assistant Professor, Konyang University Hospital: Mass Screening; Endoscopy, Gastrointestinal; Stomach Neoplasms; Metaplasia; Diagnosis; Acetic acid; Chromoendoscopy
• Additional relevant MeSH terms: Stomach Neoplasms; Metaplasia; Acetic Acid; Retinol acetate

Study Results

Participant Flow

Recruitment Details	Dates of the recruitment period: From Oct 2011 to Mar 2012. Recruiting institute: Konyang University Hospital, via the outpatient clinic or General Examination Center.

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Period Title: Overall Study
STARTED	126
COMPLETED	105
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Overall Participants	105
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	96 91.4%
>=65 years	9 8.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.9 (9.3)
Sex: Female, Male (Count of Participants)
Female	52 49.5%
Male	53 50.5%
Region of Enrollment (participants) [Number]
Korea, Republic of	105 100%

Outcome Measures

1. Primary Outcome

Title	Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Description	Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.
Time Frame	3 months after the completion of the study (a pathologist reviewed all the biopsy slide)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Measure Participants	105
Measure lesions	525
Overall Sensitivity	78.5
Overall Specificity	94.4
Overall Accuracy	89.2
Body Sensitivity	67.1
Body Specificity	94.7
Body Accuracy	89.4
Antrum Sensitivity	80.9
Antrum Specificity	93.6
Antrum Accuracy	88.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acetic Acid Spraying
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent agreement
	Estimated Value	89.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
Description	The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently. We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.
Time Frame	One month after the completion of the study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	The same participants primary outcome analysed
Measure Participants	105
Measure lesions	505
Number [Kappa index of agreement]	0.808

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acetic Acid Spraying
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Kappa index of agreement
	Comments
Method of Estimation	Estimation Parameter	Kappa index of agreement
	Estimated Value	0.808
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.
Time Frame	up to 1week after the acetic acid chromoendoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Measure Participants	105
Epigastric discomfort	9 8.6%
Neck discomfort	2 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acetic Acid Spraying
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	persent of adverse event
	Estimated Value	10.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Acetic Acid Spraying
Arm/Group Description	Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
All Cause Mortality
	Acetic Acid Spraying
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Acetic Acid Spraying
	Affected / at Risk (%)	# Events
Total	0/105 (0%)
Other (Not Including Serious) Adverse Events
	Acetic Acid Spraying
	Affected / at Risk (%)	# Events
Total	11/105 (10.5%)
Gastrointestinal disorders
Epigastric discomfort	9/105 (8.6%)
Odynophagia	2/105 (1.9%)

Limitations/Caveats

Concomitant comparison with methylene blue chromoendoscopy was not performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.